Way to Cure HCV Adherence (WTC)

Way to Cure: Developing Effective Strategies to Promote Adherence to Hepatitis C Therapy Among Older Adults

This is a 3-arm, multi-center, patient-randomized, field evaluation of the "Way to Cure" behavioral interventions on medication adherence in HCV.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Behavioral: MedSignals Pill Box

Detailed Description

This 3-arm trial will field test the efficacy of "Way to Cure" intervention on medication adherence in Hepatitis C for 12 weeks. As part of routine clinical care all patients will receive medication counseling regarding proper use and side effects by trained nurses or pharmacists depending on the clinical site.

Arm 1: Control (n=20) - Monitoring pill box will be set into "quiet mode". This mode sends daily adherence data to the Way to Health platform each time the participant opens the pill bottle, however, does not remind the participant to take the medication. In the event no electronic signal is received by the platform for 96 hours, the RA will call the participant to assess any usability or connectivity issues.

Arm 2: Intervention - Reminders/Feedback (n=20) - Patients will receive tailored text message reminders to take the medication if in case the interval from last box opening is >30 hours (greater than 6 hours overdue). Patients will receive weekly text messages with summary cumulative adherence scores.

Arm 3: Intervention - Reminders/Feedback and Financial Incentives (n=20) - In addition to reminders with missed doses and weekly adherence feedback, patients in this arm will be eligible to receive a financial incentive each week they demonstrate perfect >85% adherence. The weekly adherence feedback message will also alert patients whether they earned the incentive for the past week.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Corporal Michael J. Crescenz VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

a) age 50 older, b) prescribed a fixed dose combination HCV regimen containing sofosbuvir/ledipasvir for 12 weeks, and 3) willing to receive text message communications.

Exclusion Criteria:

a) non-English speaking, b) have severe vision, hearing impairment precluding study participation, c) no text messaging capability, d) decompensated cirrhosis requiring hospitalization in the past 30 days, e) medication primarily given by a caregiver/facility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1: Control; MedSignals pill box will be set into "quiet mode" to track patient compliance. This mode sends daily adherence data to the Way to Health platform each time the participant opens the pill box, however, does not remind the participant to take the medication.	Behavioral: MedSignals Pill Box; Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
Experimental: Arm 2: Reminders/Feedback; MedSignals pill box will track patient compliance and the Way to Health platform will allow participants to receive tailored text message reminders to take the medication if in case the interval from last cap opening is >30 hours (greater than 6 hours overdue).	Behavioral: MedSignals Pill Box; Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
Experimental: Arm 3: Reminders/Feedback/Incentives; MedSignals pill box will track patient compliance and in addition to reminders with missed doses and weekly adherence feedback, patients in this arm will be eligible to receive a small financial incentive each week they demonstrate perfect >85% adherence. The weekly adherence feedback message will also alert patients whether they earned the incentive for the past week.	Behavioral: MedSignals Pill Box; Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pill bottle measured adherence	12 weeks of treatment

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Northwestern University; Corporal Michael J. Crescenz VA Medical Center
• Investigators: Principal Investigator: Peter Reese, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: March 19, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: P30AG034546 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No